[Solved]: “multinational pharmaceutical company has developed…

“multinational pharmaceutical company has developed new malaria vaccine that has been successfully tested n Phase I and II trials. The company commissions a team f investigators to conduct a randomized, double-blind, lacebo-controlled trial to evaluate the efficacy of the accine in combination with the standard immunization cheme. Ultimately, the company’s goal is to implement the ew vaccine in malaria-prevention programmes. Scientists n an east African country where malaria is endemic express nterest in participating in the vaccine research effort. They egin to collaborate with the pharmaceutical company inves- igators on a study protocol to test the efficacy of the vaccine or reducing malaria-related deaths in the country’s children ounger than 5 years. he research team chooses to conduct the study in a southern illage where malaria transmission is intense and year-round. n this area, the incidence of clinical malaria rises steeply after he first month of life; the incidence in infants brought to local ealth facilities with malaria or severe anaemia1 are 0.7 and .6 episodes per child per year, respectively. In this town, a istrict hospital provides curative health services, while an ctive maternal and child health (MCH) clinic delivers routine hildhood immunizations and offers a monthly weighing linic. Malaria treatment in the area relies on prompt diagno- is and chloroquine, even though 60% of local parasite strains re resistant to chloroquine.2 he researchers plan to recruit participants at the MCH linic. They will explain the trial to mothers as they bring in heir children for first immunization. The clinic nurses agree o assist with translation, but emphasize that they are very usy and might not always be available to aid in this proc- ss. To assess each mother’s comprehension of the study, he researchers will use a standard set of questions, which re written in the local language. Children of the mothers who provide informed consent will receive a first dose of he vaccine or placebo (aluminium hydroxide) when they resent for the first dose of other vaccines provided through he expanded programme on immunization (EPI) at around 1 month of age. Second and third doses will be given at 2 and months of age, respectively.” “To monitor the safety of the vaccine, the researchers will examine the children twice in the hour after vaccination, and will document any signs and symptoms of local or systemic reactions. They will further advise parents to return to the clinic if their children experience any health problems such as fever or diarrhoea. Children who develop malaria, as determined by both clinical findings and microscopy, will be treated in the district hospital according to national guide- lines (i.e. with chloroquine therapy). The number of malaria cases will serve as the main study end-point. The researchers will identify cases using a passive case-detection system which has been operating at the district hospital and MCH clinic since 1994 This system will ensure that all participants in the study who attend these health facilities are seen by medical personnel who will provide 24-hour clinical cover. A few months prior to the proposed start of the trial, the phar- maceutical company’s investigators visit the host country to meet with representatives from the department of health to finalize the research protocol. These representatives argue that the informed consent process is inappropriate and does not enable study participants to adequately understand the trial. They note that the female literacy rate is estimated to be below 40%, and that since clinic nurses have a heavy work- load, they might not have the time to act as translators. They also request that if the vaccine proves effective, all children in the country should receive free doses of the vaccine for 5 years after completion of the trial. 1 Anemia is a condition in which the haemoglobin concentration in the blood is below a defined level, resulting in a reduced oxygen-carrying capacity of red blood cells. About half of all cases of anaemia can be attributed to iron deficiency; other common causes include infections, such as malaria and schistosomiasis, and genetic factors. The major health consequences include poor pregnancy outcome, impaired physical and cognitive development, increased risk of morbidity in children and reduced work productivity in adults. Pregnant women and children are particularly vulnerable. Anaemia contributes to 20% of all maternal deaths. 2 Chloroquine has traditionally been used to treat or prevent malaria. Questions 1 What are the ethical issues raised by this study? 2 Is it appropriate for the researchers to rely on health- centre staff to assist with both translation and assessment of understanding during the informed- consent process? 3 What should be the treatment for those who get malaria? 4 What responsibility, if any, does the company have to the non-study population of the country?”